June 18, 2015

LAA Closure Device a Reality: Now What? (Video)

An expert’s take on FDA’s ‘appropriate rationale’ caveat

Oussama Wazni, MD

The FDA’s long-awaited approval earlier this year of the WATCHMAN™ left atrial appendage (LAA) closure device provides an alternative to oral anticoagulation therapy in high-risk patients with nonvalvular atrial fibrillation.


Cleveland Clinic is a non-profit academic medical center. Advertising on our site helps support our mission. We do not endorse non-Cleveland Clinic products or services. Policy

The percutaneous LAA closure device is indicated to reduce the risk of thromboembolism in patients with nonvalvular afib who:

  • Are at increased risk for stroke and systemic embolism based on CHADS2 or CHA2DS2-VASc scores and are recommended for anticoagulation therapy;
  • Are deemed by their physicians to be suitable for warfarin; and
  • Have an “appropriate rationale” to seek a nonpharmacologic alternative to warfarin, taking into account the safety and effectiveness of the device relative to warfarin.

“Since FDA left the indication open to ‘appropriate rationale’ when considering these types of patients, it’s important to define what that is in order to weigh the risks and benefits and select the best candidates,” says Oussama Wazni, MD, Director of the Outpatient Electrophysiology Department and Co-Director of the Ventricular Arrhythmia Center in Cleveland Clinic’s Section of Cardiac Electrophysiology and Pacing.

In this video, Dr. Wazni discusses his clinical criteria for “appropriate rationale”: Patients with a history of bleeding when taking oral anticoagulants, or those whose future risk of bleeding is deemed to be high. He adds: “Implanting the WATCHMAN device in these patients would prevent stroke, while at the same time avoiding the risk of bleeding.”


Related Articles

December 14, 2021
New Guideline Helps Evaluate Risk in Patients With Chest Pain

Further acute testing not needed if ECG and high-sensitivity troponin are negative

November 6, 2020
New Head of Vascular Medicine Looks to Enhance Collaborative Caregiving

Scott Cameron, MD, PhD, also brings wide-ranging research interests to bear

September 30, 2020
Dr. Matthew Thompson Brings a Distinctly International Perspective to Endovascular Interventions

Pioneering U.K. vascular surgeon joins Cleveland Clinic

September 24, 2020
Stroke Risk in Cardiac Surgery: New Guidance for Averting a Dreaded Complication

AHA statement is first comprehensive document on perioperative stroke reduction

20-HVI-1896881 vascular-surgery-650×450
July 17, 2020
Cleveland Clinic Earns 3 Stars in Vascular Quality Initiative Registry Participation Program

Recognition reflects prioritization of long-term patient outcomes

20-HVI-1898975 Singh_Guidelines on CV imaging in athletes_CQD_650x450_993744768
June 15, 2020
First Formal Guidance Issued on Multimodality Cardiac Imaging in Young Athletes

Recommendations help distinguish exercise-induced remodeling from pathology

May 29, 2020
Guideline Update on Primary Cardiovascular Prevention in Women Takes on Conventional and Sex-Specific Risks

JACC review highlights factors unique to women, ways to tailor management

May 12, 2020
Trio of Studies at Virtual HRS Meeting Showcase Catheter Ablation Advances

Pushing the envelope in ablation of atrial fibrillation, ventricular tachycardia